{"entity":{"id":"liposomal-irinotecan","kind":"drug","name":"Liposomal irinotecan","aka":[],"tldr":"Irinotecan wrapped in a fat bubble so it circulates longer. It is approved for pancreatic cancer, and in bile duct and gallbladder cancer one Korean trial found it helped as second-line treatment while a German trial did not.","summary":"Liposomal irinotecan is a nanoliposomal formulation of irinotecan that prolongs circulation of the active metabolite SN-38 and increases tumour exposure. It is approved for metastatic pancreatic adenocarcinoma after gemcitabine-based therapy (NAPOLI-1; United States 2015, European Union 2016) and, with oxaliplatin, fluorouracil and leucovorin (NALIRIFOX), as first-line treatment of metastatic pancreatic adenocarcinoma (NAPOLI 3; United States 2024). In biliary tract cancer it has no licence. The Korean NIFTY phase 2b trial randomised 174 patients who had progressed on gemcitabine and cisplatin to fluorouracil and leucovorin with or without liposomal irinotecan: blinded central review progression-free survival was 7.1 versus 1.4 months (hazard ratio 0.56) at the first analysis and 4.2 versus 1.7 months (hazard ratio 0.61) when the scans were re-read with extended follow-up, with grade 3 to 4 neutropenia in 24 percent versus 1 percent. The German NALIRICC trial (100 patients) found no benefit, and the earlier German NIFE trial compared it non-comparatively with gemcitabine and cisplatin in first line. NCCN lists it as an option after gemcitabine and cisplatin; in the UK it is not commissioned for biliary cancer, where FOLFOX (ABC-06) is the second-line standard. UGT1A1 poor metabolisers need dose reduction.","status":"approved","asOf":"2026-09-24","wikipedia":"https://en.wikipedia.org/wiki/Irinotecan","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8b58efa-1820-48a4-b70d-62918fc4abfc"},{"label":"NIFTY, Lancet Oncology 2021","url":"https://doi.org/10.1016/S1470-2045(21)00486-1"},{"label":"NIFTY updated analysis, JAMA Oncology 2023","url":"https://doi.org/10.1001/jamaoncol.2023.0016"}],"tags":[],"related":[],"cancers":["gallbladder","cholangiocarcinoma","pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy","topoisomerase-inhibitors"],"targets":[],"drugs":[],"companies":["ipsen","servier"],"institutions":[],"pathways":[],"terms":[],"trials":["nifty","nife","naliricc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Onivyde","code":"nal-IRI, MM-398, PEP02","modality":"Liposome-encapsulated topoisomerase I inhibitor (cytotoxic)","mechanism":"Liposomal delivery of irinotecan; SN-38 traps topoisomerase I and DNA in cleavage complexes.","approvals":[{"region":"US","year":2015,"indication":"Metastatic pancreatic adenocarcinoma after gemcitabine-based therapy, with fluorouracil and leucovorin (NAPOLI-1)","note":"FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8b58efa-1820-48a4-b70d-62918fc4abfc"},{"region":"EU","year":2016,"indication":"Metastatic pancreatic adenocarcinoma after gemcitabine, with fluorouracil and leucovorin","note":"EMA EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal"},{"region":"US","year":2024,"indication":"First-line metastatic pancreatic adenocarcinoma in NALIRIFOX (NAPOLI 3)","note":"FDA label (DailyMed)"}],"mechanismSteps":[],"dosing":{"route":"Intravenous","schedule":"70 mg/m² over 90 minutes every 2 weeks with leucovorin 400 mg/m² and fluorouracil 2,400 mg/m² over 46 hours (NIFTY schedule)","modifications":"Reduced dose for UGT1A1*28 homozygotes","monitoring":"Neutrophil count, diarrhoea"},"toxicity":[{"event":"Neutropenia (grade 3-4)","grade3PlusPct":24,"source":"https://doi.org/10.1016/S1470-2045(21)00486-1","note":"NIFTY, liposomal irinotecan arm"},{"event":"Fatigue or asthenia (grade 3-4)","grade3PlusPct":13,"source":"https://doi.org/10.1016/S1470-2045(21)00486-1","note":"NIFTY"}],"access":[],"regulatoryEvents":[]},"route":"/drugs/liposomal-irinotecan/","neighbours":{"cancer":[{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"company":[{"id":"ipsen","kind":"company","name":"Ipsen","route":"/companies/ipsen/"},{"id":"servier","kind":"company","name":"Servier","route":"/companies/servier/"}],"trial":[{"id":"nct07099794","kind":"trial","name":"A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen","route":"/trials/nct07099794/"},{"id":"nct06438822","kind":"trial","name":"Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma","route":"/trials/nct06438822/"},{"id":"nct06993025","kind":"trial","name":"Ivonescimab in Combination With Liposomal Irinotecan and 5-FU/LV in Potentially Resectable Biliary Tract Malignancies","route":"/trials/nct06993025/"},{"id":"nct07797816","kind":"trial","name":"Liposomal Irinotecan Plus 5-FU/LV and Sintilimab With Sequential SBRT for Locally Advanced Biliary Tract Cancer","route":"/trials/nct07797816/"},{"id":"naliricc","kind":"trial","name":"NALIRICC (AIO)","route":"/trials/naliricc/"},{"id":"nct04005339","kind":"trial","name":"NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer","route":"/trials/nct04005339/"},{"id":"nife","kind":"trial","name":"NIFE (AIO-YMO HEP-0315)","route":"/trials/nife/"},{"id":"nifty","kind":"trial","name":"NIFTY","route":"/trials/nifty/"}]}}